Comparison of Effectiveness and Safety of Triple Combination Cream of Fucinolone Acetonide 0.01%, Hydroquinone 4%, Tretinoin 0.05% with Mometasone Furoate 0.1%, Hydroquinone 4%, Tretinoin 0.05% in the Treatment of Melasma

Launched by INDONESIA UNIVERSITY · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different creams to treat melasma, a skin condition that causes dark patches, usually on the face. The researchers want to compare the effectiveness and safety of a cream containing flucinolone acetonide, hydroquinone, and tretinoin with another cream that has mometasone furoate, hydroquinone, and tretinoin. Both creams are designed to help lighten the dark spots associated with melasma.

To participate in the study, women aged 30 to 59 with skin types IV or V, who have been diagnosed with melasma, may be eligible. However, women who are pregnant, breastfeeding, or have recently used certain treatments for melasma or other skin conditions won't be able to participate. Participants can expect to use one of the creams for 12 weeks and will be monitored for any side effects and how well the treatment works. This trial is still in the planning stage and has not started recruiting participants yet.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women
• • Diagnosed with melasma based on clinical and Wood's lamp examination
• • 30-59 years old
• • Skin type IV or V
• Exclusion Criteria:
• • Plan to be pregnant and breastfeeding women during the study period ( 12 weeks)
• • using or have used hormonal contraception in the last 6 months, or plan to use hormonal contraception during the study period (12 weeks)
• • Using topical melasma treatments such as corticosteroids, tretinoin, hydroquinone, and other skin whitening or lightening treatments in at least the last 2 weeks.
• • Have used topical therapy for melasma i.e. triple combination cream for at least 3 months and showed no significant improvement.
• • Using systemic therapy for melasma, e.g. antioxidants, tranexamic acid in at least the last 4 weeks.\*
• • History of eppeeling, laser or mechanical abrasion on the face in the last 6 months.\*
• • Using photosensitizer drugs such as tetracycline, phenytoin, carbamazepine, and spironolactone in at least the last 4 weeks.
• • Having other skin complaints that may interfere with the evaluation of melasma such as post-inflammatory hyperpigmentation, Hori nevus, Ota nevus, pigmented contact dermatitis, and other pigmentation disorders.
• • Difficulty in adherence to treatment such as long distance from home, work schedules, and busy activities.